Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Minimal invasive intra-arterial prostaglandin therapy is currently being offered as an established and safe treatment approach for Non-occlusive mesenteric ischemia (NOMI). So far, there are no data that prospective evaluate clinical response parameters of this method and corresponding criteria for response.
The investigators are therefore planning a prospective observational study on NOMI patients with the aim to collect
From these three data packages, the investigators hope to subsequentially derive criteria to better predict response to therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-arterial Prostglandin therapy | Minimal invasive Cannulation of the Superior Mesenteric Artery (SMA) and subsequent intra-arterial application of prostaglandin E1 (Initial Bolus 20ug, followed by continuous Infusion of 60-80ug/24hr for 24-72hrs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostavasin | Drug | Minimal invasive Cannulation of the Superior Mesenteric Artery (SMA) and subsequent intra-arterial application of prostaglandin E1 (Initial Bolus 20ug, followed by continuous Infusion of 60-80ug/24hr for 24-72hrs) |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of ischemia | Lactate reduction > 2mmol/l from baseline | 24 hours following intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | key secondary outcome | 28 days following intervention |
| Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours | as indicator of Shock reversal |
Not provided
Inclusion Criteria:
- persistent shock: Norepinephrine dose > 0.2ug/kg/min over > 48hrs
and
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients admitted to the ICU with persistent shock, intestinal failure as well as new onset and progressive organ failure with a CT and angiography based diagnosis of Non-occlusive mesenteric ischemia (NOMI)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Markus Busch, MD | Clinic for gastroenterology and hepatology | Principal Investigator |
| Klaus Stahl, MD | Clinic for nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35379286 | Derived | Rittgerodt N, Pape T, Busch M, Becker LS, Schneider A, Wedemeyer H, Seeliger B, Schmidt J, Hunkemoller AM, Fuge J, Knitsch W, Fegbeutel C, Gillmann HJ, Meyer BC, Hoeper MM, Hinrichs JB, David S, Stahl K. Predictors of response to intra-arterial vasodilatory therapy of non-occlusive mesenteric ischemia in patients with severe shock: results from a prospective observational study. Crit Care. 2022 Apr 4;26(1):92. doi: 10.1186/s13054-022-03962-w. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012769 | Shock |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
Not provided
Not provided
Not provided
Not provided
Not provided
serum and plasma
| 24 hours following intervention |
| simplified NOMI score, range 0-7 points with higher scores indicating more severe NOMI | angiographic characteristics of vasodilation following Initial Prostaglandin bolus | immediately following first intra-arterial bolus |
| peak density (PD) as measured by 2D perfusion angiography | angiographic characteristics of vasodilation following Initial Prostaglandin bolus | immediately following first intra-arterial bolus |
| area under the curve (AUC) as measured by 2D perfusion angiography | angiographic characteristics of vasodilation following Initial Prostaglandin bolus | immediately following first intra-arterial bolus |
| time to peak (TTP) as measured by 2D perfusion angiography | angiographic characteristics of vasodilation following Initial Prostaglandin bolus | immediately following first intra-arterial bolus |
| intestinal fatty acid-binding protein (I-FABP), smooth muscle protein of 22kDa (SM22) liver fatty acid-binding protein (L-FABP) | markers of ischemic intestinal barrier dysfunction | 24 hours following intervention |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |